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Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System (TORS)

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Da Vinci Robotic Transoral Robotic Surgical System
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
  • Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion Criteria:

  • Unexplained fever and/or untreated, active infection
  • Patient pregnancy
  • Previous head and neck surgery precluding transoral/robotic procedures
  • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transoral Robotic Surgery (TORS)

Arm Description

Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System

Outcomes

Primary Outcome Measures

The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis

Secondary Outcome Measures

Operative Time
The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.
Number of Participants With Blood Loss and Complications
Average Time to Set up and Perform Procedures
This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.
Number of Correctly Predicted Success of TORS Preoperatively
This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
QOL
Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.

Full Information

First Posted
January 21, 2010
Last Updated
November 13, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01059357
Brief Title
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
Acronym
TORS
Official Title
A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Detailed Description
Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transoral Robotic Surgery (TORS)
Arm Type
Experimental
Arm Description
Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
Intervention Type
Device
Intervention Name(s)
Da Vinci Robotic Transoral Robotic Surgical System
Other Intervention Name(s)
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
Intervention Description
(TORS) Da Vinci Robotic Transoral Robotic Surgical System
Primary Outcome Measure Information:
Title
The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
Description
In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis
Time Frame
At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
Secondary Outcome Measure Information:
Title
Operative Time
Description
The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.
Time Frame
At time of surgery, up to 3 hours
Title
Number of Participants With Blood Loss and Complications
Time Frame
6 months
Title
Average Time to Set up and Perform Procedures
Description
This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.
Time Frame
At time of surgery, up to 3 hours
Title
Number of Correctly Predicted Success of TORS Preoperatively
Description
This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.
Time Frame
preoperative
Title
QOL
Description
Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx) Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation Exclusion Criteria: Unexplained fever and/or untreated, active infection Patient pregnancy Previous head and neck surgery precluding transoral/robotic procedures The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua D. Waltonen, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System

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